Enables FDA compliant, in-house milling of custom abutments
Elos Medtech, a leading development and production partner for medical devices and components, has announced the US launch of its Elos Accurate® Pre-Milled Blank Solutions. The solutions give labs validated workflows for control over their in-house milling of custom abutments.
“The launch is a milestone in our quest to cut turnaround times, improve margins and optimize outcomes for end users,” says Søren Olesen, Chief Commercial & Operation Officer Dental at Elos Medtech. “Labs can now mill titanium abutments in-house with complete control over quality and timing. Just as important, labs don’t have to worry about meeting FDA regulations—we’ve already taken care of that with our 510(k) clearance.”
Elos Accurate® Pre-Milled Blank Solutions include: pre-milled blanks for in-house custom abutment milling, holder, FDA- and MDR-compliant pre-approved workflows between CAD, CAM and devices, and an open library available in 3shape and exocad.
Milling customer-specific abutments is classified as the manufacture of a Class II medical device in the US. Labs must therefore entrust the task to an external validated milling center, or procure products with a 510(k) pre-market clearance and registration for a validated digital dentistry workflow. “Using external milling centers,” says Olesen “means labs lose control over their workflow. With the Elos Accurate® Pre-Milled Blank Solutions, however, we offer labs an FDA-cleared list of pre-approved workflows between CAD, CAM and devices.”
The pre-milled blanks included in the solution are made from titanium grade 5, with each ,blank featuring the new GuideLock™ self-positioning clamp system to maximize stability. The holder can hold up to six blanks during a single milling operation, helping to cut handling times and boost efficiency. The holder is modular, allowing for quick and easy disassembly, cleaning and reassembly. Accurate® Pre-Milled Blank Solutions are available for imes icore, Planmeca and vhf milling machines.
“The solution,” says Olesen, “is a turning point for labs, clinics and the entire industry in the US. Even more labs and clinics now stand to reap the clinical and commercial benefits of seamless digital dentistry—without incurring the burden of costly, time-consuming regulatory compliance.”
To learn more about Accurate® Pre-Milled Blank Solutions and their benefits, click here.
